(27 days)
Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.
The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.
The provided text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Result |
|---|---|---|
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | Pass |
| Qualification Testing with intended Biological Indicators | Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on Reduced Incubation Time for intended Celerity 5 HP Biological Indicators and Celerity 20 HP Biological Indicators. (This means that the rapid fluorescent reading of the Celerity Incubator should correctly identify 97% or more of the biological indicators that would show growth after a full 7-day incubation period, as per FDA guidelines for reduced incubation time.) | Pass |
| Recognition of additional barcodes | Incubator reads barcodes correctly. | Pass |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).
- Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone Performance (Algorithm Only)
Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.
7. Type of Ground Truth Used
The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.
8. Sample Size for the Training Set
Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device in the context of AI/ML.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).